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Session 8: Current Issues in Adaptive Design and Evolving ICH E20 Guidance and Closing Remarks
Session Chair(s)
Erik Pulkstenis, PhD
Vice President, Data and Statistical Sciences
Abbvie, United States
Fairouz Makhlouf, PhD
Deputy Director, Office of Biostatistics, Office of Translational Science, CDER
FDA, United States
Adaptive designs have received significant attention over the last 15 years in the literature, regulatory guidance, and clinical trial practice as their use has increased supporting both early/mid-stage trials as well as registrational trials. The potential advantages including ethical considerations, accelerated decision making and efficient resource utilization are well known as are associated challenges like type-1 error control, estimation, and vigilance required to maintain trial integrity in the context of mid-trial data analysis and decision making. Regulatory guidance has emerged from around the world and ICH harmonization is currently ongoing. In this session, we will hear from key members of the ICH E20 working group who will orient us to the process as well as discuss a variety of issues that require careful thought in the implementation of these trials.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain the objectives of ICH E20 and the associated harmonization process
- Describe some of the key issues related to adaptive designs
Speaker(s)
ICH E20 Adaptive Design Guidance Development Process and Status Update
John Zhong, PhD
REGENXBIO, Inc., United States
Vice President, Head of Biometrics
ICH E20 Adaptive Design Considerations and Current Issues
John Scott, PhD, MA
FDA, United States
Division Director, Office of Biostatistics, CBER
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